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Arjohuntleigh AB

Sweden·SE-MF-000000696

Last updated September 17, 2026

Information

Country: Sweden
Address: Hans Michelsensgatan 10, Malmö, Sweden
Website: www.arjo.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +46 10 335 4500
PRRC Contact: Maria Fagerberg
EUDAMED SRN: SE-MF-000000696
FDA FEI Number: 3002806395
DUNS Number: 355804758

Catalogue (2190)

Page 13 of 44

Device	Model / Reference	Registries	Class	Status
Maxi Sky 2	MS010-01-99	EUDAMED	Class I	Active
Enterprise 5000x	E5X3OZ106AFAZA	EUDAMED	Class I	Active
Maxi Sky 2	MS000-02-06	EUDAMED	Class I	Active
Citadel Plus	FXX21C4B1AKABA	EUDAMED	Class I	Active
Maxi Move	KMCLAN-C-05	EUDAMED	Class I	Active
Maxi Move	KMCSXN-07	EUDAMED	Class I	Active
Maxi Sky 2	MS115-01-16	EUDAMED	Class I	Active
Enterprise 8000x	8X23GE103BFABA	EUDAMED	Class I	Active
Enterprise 5000x	E5X3CN117ACAJA	EUDAMED	Class I	Active
Enterprise 8000x	8X23HY113BFAJA	EUDAMED	Class I	Active
Maxi 500	KM560380-37	EUDAMED	Class I	Active
AtmosAir Velaris	633019RO	EUDAMED	Class I	Active
Symbliss Bath Chair	SYBCB001-AT	EUDAMED	Class I	Active
Enterprise 5000x	E5X3OY116CDDBA	EUDAMED	Class I	Active
Enterprise 9000x	9X22CL111FFCSA	EUDAMED	Class I	Active
Maxi Sky 2	MS000-01-05	EUDAMED	Class I	Active
Woundexpress	WE100G	EUDAMEDFDA UDI	Class IIa	Active
Enterprise 9000x	9X21AE101BFABA	EUDAMED	Class I	Active
Maxi Sky 1000	LF21400-EUUK	EUDAMED	Class I	Active
Evenda	EM92AXE1MLRAAVA	EUDAMED	Class I	Active
Hydroven	510LI92	EUDAMEDFDA UDI	Class IIa	Active
Sling - Amputee clip toilet	MAA2091M0M	EUDAMED	Class I	Active
AtmosAir Velaris	633019FI	EUDAMED	Class I	Active
Sling - Bariatric loop hammock	MAA8030-L	EUDAMEDFDA UDI	Class I	Active
Sara Flex seated transfer sling	TSS.511	EUDAMEDFDA UDI	Class I	Active
Citadel Plus	FXX21C4B1AABBA	EUDAMED	Class I	Active
Citadel Plus	FXX21A4B1ACFBB	EUDAMED	Class I	Active
Maxi Sky 2	MS000-01-08	EUDAMED	Class I	Active
AtmosAir Velaris	633027FI	EUDAMED	Class I	Active
Evenda	EN21ABD2JLKAAZA	EUDAMED	Class I	Active
Sling - Amputee clip bathing in situ	MAA2080M0M	EUDAMED	Class I	Active
Symbliss Bath Chair	SYBCS001-PT	EUDAMED	Class I	Active
Maxi Sky 2	MS110-01-16	EUDAMED	Class I	Active
Maxi Move	KMCSAE-18	EUDAMED	Class I	Active
Alpha Active 5	648205ES	EUDAMED	Class IIa	Active
Maxi Sky 2 Plus	MS000-10-10	EUDAMED	Class I	Active
Maxi Sky 2	MS110-01-11	EUDAMED	Class I	Active
Enterprise 5000x	E5X1BA001AABOA	EUDAMED	Class I	Active
Enterprise 5000x	E5X1AL001ACAJA	EUDAMED	Class I	Active
Maxi Sky 440	LE00000-EUUK	EUDAMED	Class I	Active
Enterprise 8000x	8X23HL113BFABA	EUDAMED	Class I	Active
Smartsigns	LP110-S	EUDAMED	Class IIb	Active
Pentaflex	250SL000/000P	EUDAMEDFDA UDI	Class I	Active
Sling - Loop in situ sling – padded legs	MLAAS20000S	EUDAMED	Class I	Active
Citadel	CXX21A4F1ABRA0	EUDAMED	Class I	Active
Auralis	636001	EUDAMED	Class IIa	Active
Minstrel	HMA0001-UK	EUDAMED	Class I	Active
Maxi Sky 2	MS000-02-11	EUDAMED	Class I	Active
Maxi Move	KMCSAE-99	EUDAMED	Class I	Active
AtmosAir Velaris	633016HU	EUDAMED	Class I	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (6)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Sep 11, 2013	Z-0926-2014	—	terminated	The lock pin can become stuck in the "in" position during the manual rotation, resulting in the inability to prone a patient
Aug 18, 2009	Z-2230-2009	—	terminated	A Scoop Stretcher is made up of two frames that are held together with two locking devices, one on each end. Each locking device contains a safety latch. The safety latch could unintentionally release when the side frames are pulled for positioning.
Jun 11, 2009	Z-1946-2009	—	terminated	Male patient genitals may be pinched between the seat and the frame of the patient lift chair when the Care Raiser seat is returned to its lowest position.
Apr 27, 2009	Z-1945-2009	—	terminated	The roll pin on certain configurations of the Maxilift hanger bar could break due to a combination of severe corrosion and fatigue. Breakage of the roll pin would lead to the detachment of the hanger bar from the jib of the lifter.
Feb 26, 2009	Z-1637-2009	—	terminated	If the sling clips are not applied or are applied incorrectly, there is the potential for the patient to fall, resulting in injury to both the patient and/or the caregiver.
Feb 26, 2009	Z-1636-2009	—	terminated	If the sling clips are not applied or are applied incorrectly, there is the potential for the patient to fall, resulting in injury to both the patient and/or the caregiver.

FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Arjohuntleigh, Inc. US